ManoScan MSS-4581-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260167483719), received between Sep 23, 2021 and Sep 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE BALLOON DID NOT DEFLATE AND THEY HAD TO PUNCTURE IT TO BE REMOVED. THEY PUT 300 ML INTO THE BALLOON THEN THE CUSTOMER GOT 60 ML OUT VIA SYRINGE AND THEY COULD NOT REMOVE ANY MORE; IT WOULD NOT PULL THE AIR BACK. THE CUSTOMER MOVED THE Y-CONNECTOR AROUND AND TRIED TO PUT 20 ML BACK BUT IT WOULD NOT GO IN. THEY TRIED TO REMOVE IT AGAIN AND ONLY 30 ML CAME BACK. THE CUSTOMER DISCONNECTED ALL LINES AND TRIED TO BYPASS THE Y-CONNECTOR BUT IT DID NOT WORK. THE PHYSICIAN POPPED THE BALLOON BUT IT DID NOT COME OUT WITH THE REST OF THE CATHETER COVER DURING THE REMOVAL OF THE CATHETER. A PART OF THE BALLOON SHEATH WAS LEFT IN-SITU TO BE REMOVED VIA NATURAL BODY MOTIONS. THE CATHETER WORKED CORRECTLY DURING PREVIOUS PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12519071 ↗